D-Anchor QR&C LLC. can help you obtain a DUNS number, the Device Identifier (DI) from the accredited agency, and serve as your regulatory Contact for proper submission of your UDI/Device information to the FDA via GUDID.

Note:

A device labeler complying with UDI requirements is required to have a DUNS number, which is used to identify the labeler in GUDID.

UDIs have a device identifier (DI) and a production identifier (PI). The DI must be issued by an FDA accredited agency. The PI is determined by production information, such as the lot or batch number. A separate UDI is needed for every version or model of each device.

Device labelers are also required to identify a Global Medical Device Nomenclature (GMDN) code for each device submitted to the GUDID.  The GMDN code represents an international standard for describing a specific device.